EyeNet Magazine



   
 
Guest Opinion
Some Thoughts on the FDA Ophthalmic Devices Panel on LASIK
By Jayne S. Weiss, MD, Acting Chairwoman, FDA Ophthalmic Devices April 2008 Meeting
 
 

As a refractive surgeon, I know that LASIK works. I have many happy patients who feel that seeing without glasses has transformed their lives. Of course, I see some patients who are unhappy and even fewer who are extremely unhappy with the results of their LASIK. Of course, these patients have typically had surgery done by other surgeons (only partially joking here . . .).

The April FDA ophthalmic devices panel meeting on LASIK, which I chaired, underscored a blind spot in the vision of many refractive surgeons: what we do with the unhappy LASIK patient. While we can keep on emphasizing how successful LASIK is and talk about the high percentage of patients who are satisfied, we must also discuss those who are not satisfied.

The arithmetic is simple. If we estimate a 0.5 percent post-LASIK complication rate leading to visual disability, this translates to 5,000 complications per 1 million procedures. It isn’t difficult to compute that, despite the small percentage, the absolute number of unhappy patients is growing and will continue to grow as more LASIK is done.

Some of these patients were at the FDA panel meeting. While there were patients who testified glowingly about their LASIK results, many others described their despair from marked visual disabilities. Some patients observed that refractive surgeons have created a procedure that has the potential to result in problems that we do not know how to fix. And it is true that we do not always have definitive treatment to address fixed microfolds in the flap, decentered ablations, recurrent epithelial ingrowth and other complications.

How can we respond? Our defense is that we informed the patient, their expectations were unreasonably high, they see better without their glasses than they did before the LASIK, and they signed the consent, which clearly indicated there were no guarantees and that complications were possible.

Of course, this is completely unsatisfactory to the patient who encounters the effects of disabling ghost images, intractable dry eye or other symptoms. Do some of these patients have underlying psychological issues? Are some of them perfectionist or just unreasonably demanding? Yes, but, we must acknowledge that some patients have real postoperative complications after LASIK. At the panel meeting, at least one patient observed that once he developed a postsurgical complication, advice became scarce. It is at this time that patients are most in need of skilled diagnosis, advice and, at times, intervention.

All ophthalmologists will be seeing more individuals who have post-LASIK complaints or complications. What do these patients want? First, the simple acknowledgment that there is indeed an objective problem that correlates with their symptoms. More than one patient testifying at the meeting spoke of feelings of abandonment when they continued to be falsely reassured that everything was going well after their LASIK, even while they complained of difficulty seeing. Certainly, the current litigious climate may make the discussion of postoperative complications difficult, but some patients just want to understand the reason for their visual complaints. Second, we need to be committed to continuing to research and develop better treatments for these complications. LASIK is a highly successful and extremely safe procedure, but not for everyone. As doctors, we have the duty to acknowledge and treat both our successes and our failures.

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